The Spinal-EZE™ Intraoperative Epidural Catheter Kit is intended to provide intraoperative single dose delivery of local anesthetic and/or narcotics to the epidural space adjacent to the cauda equina when the epidural injection is accessible as a result of surgery to the spinal column through the epidural space. The only clinical setting for administration for the Spinal-EZE™ Intraoperative Epidural Catheter is intraoperative. The device is provided sterile and is intended for single-use only.

Device Description

The Spinal-EZE™ Intraoperative Epidural Catheter Kit consists of a catheter assembly with a .027" ID x .060" OD that is 60 cm long with an atraumatic bullet shaped closed tip. The catheter has depth marks at 100mm increments and 6 pairs of punched holes .56mm to .61mm in diameter positioned 90° apart at 3mm increments beginning 19.99mm from the catheter tip. The catheter is manufactured from 60 durometer Barium sulfate loaded (5%) silicone elastomer. Also included in the kit is a 10cc Syringe marked "epidural", a blunt tip 65cm long Teflon coated guide wire to assist in maneuvering the catheter during insertion, a Luer lock and cap assembly to facilitate attachment of the catheter to the syringe.

AI/ML Overview

The provided text is a 510(k) summary for the Spinal-EZE™ Intraoperative Epidural Catheter Kit. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the way a clinical trial for a novel device would.

Therefore, the requested information elements related to a comparative effectiveness study, standalone algorithm performance, number of experts for ground truth, sample sizes for training/test sets, and detailed adjudication methods are not explicitly present in this 510(k) summary. These summaries typically highlight technical characteristics and biological safety rather than clinical performance metrics in the same way.

However, I can extract the information that is present and explain why certain information is missing based on the nature of the document.

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this context refers to demonstrating that the new device is as safe and effective as the predicate devices, primarily through similarity in design features, performance, and indications for use.

Acceptance Criteria (Demonstrated Equivalence)	Reported Device Performance (Summary of Testing)
Similarities in design features	Catheter assembly: 0.027" ID x 0.060" OD, 60 cm long, atraumatic bullet-shaped closed tip, depth marks (100mm increments), 6 pairs of punched holes (0.56mm-0.61mm diameter, 90° apart at 3mm increments starting 19.99mm from tip). Manufactured from 60 durometer Barium sulfate loaded (5%) silicone elastomer.
Similarities in performance	Closed end with lateral/radial side hole catheter, intended for intraoperative use. Fluid path materials in conformance with ISO 10993 Part 1 for Fluid path contact.
Similarities in indications for use	Intended to provide intraoperative single dose delivery of local anesthetic and/or narcotics to the epidural space adjacent to the cauda equina when the epidural injection location is accessible as a result of surgery to the spinal column through the epidural space. Only for intraoperative administration, sterile, single-use.
Biological Safety	All materials evaluated through biological qualification safety tests as outlined in ISO 10993-1 Part 1 "Biological Evaluation of Medical Devices". Results indicate the device is safe and effective.
Other characteristics	Intended use, precautions, contraindications, sterilization method, labeling and packaging indicate substantial equivalence to predicate devices.

Study Details

Given this is a 510(k) summary, detailed clinical study methodologies for proving specific performance metrics (like sensitivity, specificity, accuracy) are not typically included as they would be for more novel or high-risk devices. The "study" here refers to the comparison and testing done to support substantial equivalence.

Sample size used for the test set and the data provenance:
- Not explicitly stated in the document. The testing mentioned (biological qualification safety tests, design control activities) refers to engineering and material testing, not a clinical "test set" of patient data.
- The "data provenance" is derived from internal design and testing of the device and comparison to predicate devices, rather than external clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/not stated. This type of information would be relevant for studies involving human interpretation (e.g., image analysis), which is not the primary focus of this device's submission. The "ground truth" for this device's submission revolves around demonstrating material safety and functional equivalence to established devices.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/not stated. Similar to point 2, this method is typically used for clinical consensus in diagnostic studies.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is an intraoperative catheter kit, not an AI or diagnostic imaging device. An MRMC study is not relevant to its submission.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a medical device (catheter kit), not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is based on established material standards (ISO 10993-1), engineering design principles, and the known performance characteristics of the legally marketed predicate devices. There is no mention of patient-level outcomes data or pathology as primary ground truth for this 510(k).
The sample size for the training set:
- Not applicable/not stated. This is not an AI/machine learning device.
How the ground truth for the training set was established:
- Not applicable/not stated. This is not an AI/machine learning device.

Summary of the Study (as described in the 510(k) summary):

The "study" undertaken for the Spinal-EZE™ Intraoperative Epidural Catheter Kit was primarily a substantially equivalent comparison to predicate devices and biological and design control testing.

Comparison Study: The device's design features, performance characteristics, and indications for use were directly compared to the I-Flow Corporation's Intra Op Catheter (K991543) and Aries Medical, Inc. (Teleflex Medical)'s Epidural Catheter (K840202). The conclusion was that the subject device exhibits "similarities in design features, performance and indications for use" to these predicates.
Biological Safety Study: "All materials used in the fabrication... were evaluated through biological qualification safety tests as outlined in ISO 10993-1 Part 1 'Biological Evaluation of Medical Devices'."
Design Control: "Design control activities have been completed and the results indicate that the subject device is safe and effective." This would encompass various engineering tests (e.g., tensile strength, flow rates, tip integrity, depth marking accuracy, hole patency) to ensure the device meets its design specifications, though specific details of these tests are not provided in the summary.

Conclusion: The 510(k) summary concludes that, based on this testing and comparison, the device is "substantially equivalent to the predicate devices" and is "safe and effective." The FDA's letter confirms this finding of substantial equivalence.

Summary

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Koyiyoy

OCT 2 1 2008

Spinal Integration, LLC

P.O. Box 1669 · Windermere, FL 34786-1669 (407 313-3195 · Fax (407) 292-4136

510k SUMMARY

Company Information ::

Spinal Integration LLC 6314 Kingspointe Pkwy Unit 6 Orlando, Florida 32819 Telephone: (800) 937-7949 Facsimile: (407) 392-4133 Contact: Dan Becker General Manager

May 15, 2008 Summary Prepared:

Device Identification:

Proprietary/Trade Name: Spinal-EZE™ Intraoperative Epidural Catheter Kit Common/Usual Name: Anesthesia Conduction Catheter Classification Name: Catheter, Conduction Anesthetic Class II Device Class: Device/Product Code: BSO 21CFR 868.5120 Requlation Number Anesthesiology Classification Panel: Predicate Devices: Intra Op Catheter, I-Flow Corporation, BSO, (K991543) Epidural Catheter, Aries Medical, Inc. (Teleflex Medical) BSO, (K840202) The Spinal-EZE™ Intraoperative Epidural Catheter Kit is

Indications for Use: intended to provide intraoperative single dose delivery of local anesthetic and/or narcotics to the epidural space adjacent to the cauda equina when the epidural injection location is accessible as a result of surgery to the spinal column through the epidural space. The only clinical setting for administration for the Spinal-EZE TM Intraoperative Epidural Catheter is intraoperative. The device is provided sterile and is intended for single-use only.

Device Description: The Spinal-EZE™ Intraoperative Epidural Catheter Kit consists of a catheter assembly with a . 027" ID x .060" OD that is 60 cm long with an atraumatic bullet shaped closed tip. The catheter has depth marks at 100mm increments and 6 pairs of punched holes .56mm to .61mm in diameter positioned 90° apart at 3mm increments

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beginning 19.99mm from the catheter tip. The catheter is manufactured from 60 durometer Barium sulfate loaded (5%) silicone elastomer. Also included in the kit is a 10cc Syringe marked "epidural", a blunt tip 65cm long Teflon coated guide wire to assist in maneuvering the catheter during insertion, a Luer lock and cap assembly to facilitate attachment of the catheter to the syringe.

The substantial equivalence of the Spinal-EZE™ Substantial Equivalence: Intraoperative Epidural Catheter is supported by its similarities in design features, performance and indications for use to the Intra Op Catheter, I-Flow Corporation (K991543) and the Epidural Catheter, Aries Medical, Inc. (Teleflex Medical) (K840202)
This device and its predicates are closed end with Technical Characteristics: lateral/radial side hole catheters intended for intraoperative use. The Spinal-EZE™ Intraoperative Epidural catheter's fluid path materials are in conformance with ISO 10993 part 1 for Fluid path contact as are the predicates Intended use, precautions, contraindications, sterilization method, labeling and packaging of the subject device and its predicates indicate to Spinal Integration that the Spinal-EZE™ Intraoperative Epidural Catheter Kit is substantially equivalent to the named predicate devices.

Summary of Testing: All materials used in the fabrication of the Spinal-EZE™ Intraoperative Epidural Catheter were evaluated through biological qualification safety tests as outlined in ISO 10993-1 Part 1 "Biological Evaluation of Medical Devices". Design control activities have been completed and the results indicate that the subject device is safe and effective.

Conclusion: The above statements are accurate representations of the device Spinal Integration intends to market. Based on all the testing and comparison Spinal Integration believes the subject device is substantially equivalent to the predicate devices. All data and information submitted in this premarket notification is truthful and accurate and no material fact has been omitted.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

OCT 2 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Trudie Seeger Regulatory Consultant Spinal Integration, LLC 6314 Kingspointe Parkway Unit 6 Orlando, Florida 32819

Re: K081404

Trade/Device Name: Spinal-EZE™ Intraoperative Epidural Catheter Kit Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO Dated: September 30, 2008 Received: October 2, 2008

Dear Dr. Seeger:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Seeger

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

J. Samuels-Redim'D for A

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K081404

Device Name: Spinal-EZE™ Intraoperative Epidural Catheter Kit

Indications for Use: The Spinal-EZE™ Intraoperative Epidural Catheter Kit is intended to provide intraoperative single dose delivery of local anesthetic and/or narcotics to the epidural space adjacent to the cauda equina when the epidural injection is accessible as a result of surgery to the spinal column through the epidural space. The only clinical setting for administration for the Spinal-EZE™ Intraoperative Epidural Catheter is intraoperative. The device is provided sterile and is intended for single-use only.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over the Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

fm Airm.D

(Division Sign Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K081404

Regulation Number and Section

§ 868.5120 Anesthesia conduction catheter.

(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).